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Advanced Technology Laboratory, Compliance & Safety, General Information, Main lab

Spectrum Health Laboratories Pass Systemwide CAP Inspection

The Laboratories at Spectrum Health recently passed a systemwide inspection from the College of American Pathologists (CAP).   Fifteen inspectors from four different laboratories around the country inspected our main regional laboratory here in Grand Rapids as well as our laboratories at Big Rapids, Gerber, Blodgett, Kelsey, Ludington, Pennock, Reed City, United and Zeeland. 

The College of American Pathologists is considered the gold standard for assessing quality lab work. The CAP Laboratory Accreditation Program began in the early 1960’s and is recognized by the federal government as being equal to or more stringent than the government’s own inspection program. It is a peer-review process where laboratories are inspected by their peers every two years. 

During the accreditation process, inspectors spent four days and traveled over 550 miles examining laboratory records, quality-control procedures, qualifications of staff, equipment, facilities, safety programs, and overall management at each of our laboratories.  This included reviewing many of our 8289 standards.  Although our Grand Rapids laboratories were inspected by CAP early last spring, and many of our community hospital labs were evaluated separately over the last two years, this was the first time our system was inspected as a whole. 

Spectrum Health Laboratory is one of more than 7,700 CAP –accredited laboratories worldwide! CAP inspections promote better patient care by constantly challenging laboratories to improve; ensure the highest quality standards are maintained and that results are reported to healthcare providers accurately and in a timely manner.

Congratulations to all of our Laboratories and Staff!

Advanced Technology Laboratory, Flow Cytometry

Oxidative Burst by Flow Cytometry Update

Effective immediately, Oxidative Burst by Flow Cytometry (#LAB2111414) will no longer require submission of the biological mother’s sample. An adult control specimen will still be required along with the patient’s specimen. For more information on specimen collection, please visit the Laboratory Catalog.

Questions may be directed to the Flow Cytometry Laboratory using the “Contact Us” link above.

Advanced Technology Laboratory, Molecular Diagnostics

Methods update on BCR-ABL1 t[9;22] RT-PCR testing

An updated BCR-ABL1 t[9;22] RT-PCR assay went live on Jan 31, 2018. The BCR-ABL major and minor fusion transcripts are measured and reported separately after this update. The quantities of BCR-ABL1 major breakpoints fusion transcripts (type e13a2 and/or e14a2) are detected by FDA approved QuantideX® qPCR BCR-ABL IS Kit and the result is calibrated and reported on the International Scale (%IS). The quantities of BCR-ABL minor fusion transcripts are detected by QuantideX qPCR BCR-ABL minor kit and the result is reported as BCR-ABL1 to ABL1 ratio (%). This update provides more precise and standard measurements of BCR-ABL fusion RNA and supports the consistency of patient care in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

Questions may be directed to the Molecular Diagnostics Laboratory using the “Contact Us” link above.

Lab Catalog link: LAB3222022: BCR-ABL1 t[9;22] RT- PCR  

Advanced Technology Laboratory, Flow Cytometry, General Information

PNH Flow Cytometry Test Results

High sensitivity flow cytometry testing for paroxysmal nocturnal hemoglobinuria (PNH) is a test done on patient’s peripheral blood to screen for the presence or absence of PNH clones and/or to follow PNH clonal populations.  The lower limit of detection of a PNH clone for the Spectrum Health laboratory has been validated as 0.01% (1:10,000) for red cells, 0.01% (1:10,000) for granulocytes and 0.1% for monocytes (1:1000).

The results from PNH flow cytometry testing can guide the clinical team in classifying a patient’s disease appropriately, analyzing the risk of disease progression, and choosing appropriate testing to monitor response to treatment. Therefore, the PNH flow cytometry test result will now include a pathologist’s interpretation based on the new recommendations given in Updated ICCS/ESCCA Consensus Guidelines for the Clinical Utility of Testing for GPI-Anchor Deficient Clones in Paroxysmal Nocturnal Hemoglobinuria (PNH) and other Bone Marrow Disorders (Accepted article by Dezern and Borowitz, doi: 10.1002/cyto.b.21608).

Advanced Technology Laboratory, Flow Cytometry

Flow Cytometry Laboratory Attains Status as a Children’s Oncology Group Approved Laboratory

The Spectrum Health Flow Cytometry Laboratory is pleased to announce that it has attained status as a Children’s Oncology Group (COG) approved laboratory for minimal residual disease (MRD) testing for patients with B lymphoblastic leukemia (B-ALL). This is a reflection of the expertise and dedication of the entire flow cytometry team to accomplish this 3-year project. It also highlights the strong support and collaboration between the laboratory and pediatric hematology oncology team. Continue Reading